December 2025 Quarterly Activity Report and Appendix 4C
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Cynata Therapeutics Limited
ABN – 98 104 037 372
Level 3, 100 Cubitt Street
Cremorne
VIC 3121
Australia
T: +613 7067 6940
E: info@cynata.com
www.cynata.com
ASX ANNOUNCEMENT 29 January 2026
December 2025 Quarterly Activity Report
Key highlights:
Phase 3 osteoarthritis trial: final patient visits completed in one of the largest MSC trials
globally, with results expected in Q2 CY 2026.
Phase 2 aGvHD trial: patient enrolment completed, with results expected in June 2026.
Phase 1/2 kidney transplantation trial: first cohort completed following a positive independent
DSMB review, now progressing with second cohort.
Cash balance of ~$2.6m at quarter end, with a further ~$1.2m raised subsequent to the quarter
via the ATM facility, taking estimated available cash to ~$3.8m.
Cash runway anticipated to extend into mid-calendar year 2026.
Active engagement with regulators and global stakeholders, alongside continued evaluation of
partnering and regional development opportunities.
Cynata also further strengthened its intellectual property portfolio, securing several patent
allowances and grants across the US and Europe.
Investor webinar to be held on 4 February 2026 at 11:30am AEDT
Melbourne, Australia; 29 January 2026: Cynata Therapeutics Limited (ASX: “CYP”, “Cynata”, or the
“Company”), a clinical-stage biotechnology company specialising in cell therapeutics, is pleased to
provide its Quarterly Activity Report for the three-month period ended 31 December 2025.
During the quarter, Cynata completed patient enrolment and key clinical activities across its leading
programs, positioning the Company for two near-term clinical efficacy readouts. Patient enrolment was
completed in the Phase 2 trial in acute graft versus host disease (aGvHD), and the final patientvisits were
completed in the Phase 3 osteoarthritis trial — with results from both trials expected in Q2 CY1
2026.
In parallel, the first cohort of the Phase 1/2 kidney transplantation trial was completed following a
positive independent Data and Safety Monitoring Board (DSMB) review, with no safety concerns or
episodes of transplant rejection identified, and the trial will now progress with the second cohort of
patients.
Alongside clinical execution, the Company continued to engage with regulatory authorities to progress
potential approval pathways, while management also participated in global scientific and investment
conferences to highlight the clinical and commercial potential of the Cymerus™ iPSC2
-derived MSC3
platform.
The Company is now focused on upcoming data readouts and next-stage development planning, with
multiple clinical and strategic catalysts anticipated over the period ahead.
Dr Kilian Kelly, CEO & MD, said; “Cynata has been built for this stage of development. As our programs
move from execution to data, we are increasingly focused on translating years of platform innovation into
clear clinical and commercial outcomes for patients and shareholders.”
Phase 2 Acute Graft Versus Host Disease Trial: Results Expected Q2 2026
As announced on 15 December 2025, patient enrolment has been completed in the Company’s Phase 2
clinical trial of CYP-001 in adults with newly diagnosed, high risk aGvHD. A total of 65 participants were
Cynata Therapeutics Limited
ABN – 98 104 037 372
Level 3, 100 Cubitt Street
Cremorne
VIC 3121
Australia
T: +613 7067 6940
E: info@cynata.com
www.cynata.com
enrolled in the trial across numerous clinical centres in Australia, the USA, and Europe. Each participant
was randomised to receive either steroids plus CYP-001, or steroids plus placebo. The trial involves a
100-day primary evaluation period, which is expected to conclude in March 2026, with results
anticipated around June 2026. The primary endpoint is Overall Response Rate at Day 28.
aGvHD is a serious and often life-threatening complication of bone marrow transplantation and similar
procedures, where the donor’s immune cells (the graft) attack the recipient’s tissues (the host). aGvHD
affects up to 50% of patients who receive transplants from other donors. Standard first-line treatment
with steroids fails in around half of all aGvHD cases, which are known as “steroid-resistant” or
SR-aGvHD cases. Historical two-year survival rates in patients with SR-aGvHD are less than 20%.4
Cynata’s Cymerus™ iPSC-derived MSC product, CYP-001, is designed to modulate the immune system
and improve both response rates and survival outcomes in aGvHD. In a successful Phase 1 trial in
patients with SR-aGvHD, 87% of patients showed an Overall Response, 53% showed a Complete
Response, and 60% survived for at least two years. Importantly, there were no serious adverse events or
safety concerns related to CYP-001 treatment. This ground-breaking trial led to two publications in the
prestigious journal Nature Medicine.5,6
The US FDA has granted Orphan Drug Designation7
to CYP-001
for the treatment of aGvHD.
Phase 3 Osteoarthritis Trial: Results Expected Q2 2026
As announced on 24 November 2025, the two-year follow-up of participants in the Phase 3 SCUlpTOR8
trial of CYP-004 in patients with osteoarthritis of the knee has been completed. Results of the trial are
expected to be released in Q2 CY 2026.
Osteoarthritis is a degenerative joint condition affecting over 500 million people globally.9
Current
treatment options are limited to symptom management or invasive surgery, with no disease-modifying
therapies currently available.
CYP-004 is Cynata’s Cymerus™ iPSC-derived MSC product candidate for intra-articular injection
(injection into a joint), designed to calm joint inflammation, relieve pain and protect cartilage. The Phase
3 trial, known as the SCUlpTOR trial, is being conducted by the University of Sydney and funded through
an NHMRC10
project grant. It is being led by Professor David Hunter, the Florance and Cope Chair of
Rheumatology and Professor of Medicine at the University of Sydney and Royal North Shore Hospital.
The trial enrolled a total of 321 patients, who were randomised to receive either CYP-004 or placebo, with
co-primary endpoints assessing change in pain and cartilage thickness (disease modification).
Following an advisory meeting with the Australian Therapeutic Goods Administration, Cynata is
optimistic that positive results could support marketing approval of CYP-004 in Australia.
Phase 1/2 Kidney Transplantation Trial: DSMB Review of First Cohort Expected Q4 2025
As announced on 4 December 2025, the independent DSMB completed its planned review of the first
cohort of patients treated with CYP-001 in the Phase 1/2 NEREID kidney transplant trial.
This investigator-led 16 patient trial, conducted at Leiden University Medical Centre (LUMC) in the
Netherlands, is assessing whether CYP-001 can reduce reliance on calcineurin inhibitors, potentially
offering patients safer long-term immune modulation.
Each of the three patients in Cohort 1 received a single intravenous infusion of CYP-001 approximately
six weeks after receiving a kidney transplant, in addition to standard treatment. There were no episodes
of kidney transplant rejection in this cohort, and no safety concerns have been identified.
Following the successful DSMB review, LUMC now plans to progress with Cohort 2 in this trial. This will
involve a further three patients, each of whom will receive two infusions of CYP-001, in addition to
standard treatment.
Cynata Therapeutics Limited
ABN – 98 104 037 372
Level 3, 100 Cubitt Street
Cremorne
VIC 3121
Australia
T: +613 7067 6940
E: info@cynata.com
www.cynata.com
Patients undergoing kidney transplantation typically require lifelong immunosuppressive therapy to
prevent organ rejection, typically with drugs known as calcineurin inhibitors. These drugs are effective,
but they come with serious long-term toxicity and health risks.
Intellectual Property Portfolio
Cynata continues to strengthen its robust intellectual property portfolio, which comprises several
different in-licensed and Company-owned patent families.
During the quarter:
A Notice of Allowance was issued by the United States Patent and Trade Mark Office for a Cynata-
owned patent application entitled “Colony Forming Medium and Use Thereof”, which relates to
the optimisation of the Cymerus process.
A Notice of Intention to Grant a Patent was issued by the European Patent Office for a Cynata-
owned patent application entitled “Methods and products for delivering cells”, which relates to
the technology used in the manufacture of Cynata’s wound dressing product, CYP-006TK.
A Notice of Allowance was issued by the United States Patent and Trade Mark Office for a patent
application entitled “Methods and Materials for Hematoendothelial Differentiation of Human
Pluripotent Stem Cells Under Defined Conditions”, which relates to the core technology
underpinning the Cymerus process, which is exclusively licensed to Cynata by Wisconsin
Alumni Research Foundation.
Outlook
Cynata is entering a period focused on the analysis and reporting of clinical data from its leading
programs, with twomajor efficacy trials nearing completion. The Company expects to report results from
both its Phase 3 osteoarthritis trial and Phase 2 aGvHD trials in Q2 CY 2026, which will inform the next
stage of development and strategic decision-making.
Alongside these readouts, Cynata will continue active engagement with regulatory authorities in
Australia and internationally to clarify potential approval pathways and development requirements. The
Company is also preparing for next-stage clinical and commercial planning across its pipeline, including
evaluation of partnering, licensing and regional development opportunities where appropriate.
Cynata will also continue to assess opportunities to advance its earlier-stage programs, including kidney
transplantation and diabetic foot ulcers, building on encouraging data generated to date. The Company
remains focused on disciplined capital management to support upcoming milestones.
Finance
During the quarter, as announced on 4 November 2025, the Company received a $1.712m R&D Tax
Incentive Refund for the 2024/2025 financial year.
The Company closed the quarter with $2.588m in cash. Additionally, subsequent to the quarter end (as
announced on 23 January 2026), a further $1.204m was raised via the Company’s At-the-Market
Subscription Agreement (“ATM”) with Acuity Capital. The ATM facility, which was established in August
2025, provides the Company with a total of up to $7.5m of standby equity capital.
Net operating cash outflows for the quarter totalled $0.578m. In item 6 of the Appendix 4C cash flow
report for the quarter, payments to related parties of approximately $0.189m consisted of salary paid to
the Managing Director and fees paid to Non-Executive Directors.
In accordance with ASX rules, the “Estimated quarters of funding available” reported in item 8.5 of the
Appendix 4C is calculated by dividing the Company’s cash balance at the end of the quarter by the net
Cynata Therapeutics Limited
ABN – 98 104 037 372
Level 3, 100 Cubitt Street
Cremorne
VIC 3121
Australia
T: +613 7067 6940
E: info@cynata.com
www.cynata.com
operating cash outflows in the previous quarter, and the result of this calculation is 4.5 quarters of
funding available. The Company continues to anticipate that its cash runway will extend into mid-
calendar year 2026.
Investor Communications
Webinar
An investor webinar will be held on Wednesday, 4 February 2026 at 11:30am AEDT, hosted by CEO and
Managing Director, Dr Kilian Kelly.
Attendees are required to register in advance for the webinar – using the following link:
https://us02web.zoom.us/webinar/register/WN_3WketK2XQxSSYd1Elef27g
Upon registration, attendees will receive details to access the webinar.
InvestorHub
Last year, the Company launched a new InvestorHub portal and website, for dedicated investor
engagement. This enables shareholders, stakeholders, prospective investors and partners to learn more
about the Company's activities and key projects. The Company regularly uploads new content to the
hub, including videos, key project news and updates. Shareholders and interested parties can join
InvestorHub via the “sign up” button on the Company’s website (www.cynata.com).
-ENDS-
Authorised for release by Dr Kilian Kelly, CEO & Managing Director
CONTACTS: Dr Kilian Kelly, CEO & MD, Cynata Therapeutics, +61 (03) 7067 6940, kilian.kelly@cynata.com
Lauren Nowak, Media Contact, +61 (0)400 434 299, investors@cynata.com
About Cynata Therapeutics (ASX: CYP)
Cynata Therapeutics Limited (ASX: CYP) is an Australian clinical-stage stem cell and regenerative medicine company focused
on the development of therapies based on Cymerus™, a proprietary therapeutic stem cell platform technology. Cymerus™
overcomes the challenges and limitations of conventional MSC production by using induced pluripotent stem cells (iPSCs) to
achieve economic manufacture of cell therapy products, including mesenchymal stem cells (MSCs), at commercial scale
without the necessity to obtain tissue from multiple donors on an ongoing basis, and without the complexity and product
inconsistency resulting from conventional methods.
Cynata has demonstrated positive safety and efficacy data for its Cymerus™ product candidates CYP-001 and CYP-006TK in
Phase 1 clinical trials in steroid-resistant acute graft versus host disease (GvHD) and diabetic foot ulcers (DFU), respectively.
Further clinical trials are now ongoing: a Phase 2 trial of CYP-001 in GvHD under a cleared US FDA IND; a Phase 1/2 trial of
CYP-001 in patients undergoing kidney transplantation; and a Phase 3 trial of CYP-004 in osteoarthritis. In addition, Cynata has
demonstrated utility of its Cymerus™ technology in preclinical models of numerous other diseases, including critical limb
ischaemia, idiopathic pulmonary fibrosis, asthma, heart attack, sepsis, acute respiratory distress syndrome (ARDS) and
cytokine release syndrome.
Cynata Therapeutics encourages all current investors to go paperless by registering their details with the designated registry service
provider, Automic Group.
1
CY = calendar year
2
iPSC = induced pluripotent stem cell
3
MSC = mesenchymal stromal (or stema) cell
4
Westin JR et al. Adv Hematol. 2011;2011:601953
5
Bloor AJC, et al. Nat Med. 2020;26:1720–1725
6
Kelly K, et al. Nat Med. 2024;30:1556–1558
7
Orphan Drug Designation qualifies Cynata for incentives including extended marketing exclusivity, tax credits and fee waivers.
8
SCUlpTOR = Stem Cells as a symptom- and strUcture-modifying Treatment for medial tibiofemoral OsteoaRthritis
9
World Health Organization. Fact Sheet – Osteoarthritis. 14 July 2023
10
National Health and Medical Research Council
Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 1
+ See chapter 19 of the ASX Listing Rules for defined terms.
Appendix 4C
Quarterly cash flow report for entities
subject to Listing Rule 4.7B
Name of entity
CYNATA THERAPEUTICS LIMITED
ABN Quarter ended (“current quarter”)
98 104 037 372 31 DECEMBER 2025
Consolidated statement of cash flows Current quarter
$A’000
Year to date
(6 months)
$A’000
1. Cash flows from operating activities
- -
1.1 Receipts from customers
1.2 Payments for
(1,599) (2,598)
(a) research and development
(b) product manufacturing and operating
costs
- -
(c) advertising and marketing (87) (144)
(d) leased assets (including premises) - -
(e) staff costs (558) (1,233)
(f) administration and corporate costs (79) (278)
1.3 Dividends received (see note 3) - -
1.4 Interest received 33 80
1.5 Interest and other costs of finance paid - -
1.6 Income taxes paid - -
1.7 Government grants and tax incentives (2025
R&D Tax Incentive)
1,712 1,712
1.8 Other - -
1.9 Net cash from / (used in) operating
activities
(578) (2,461)
2. Cash flows from investing activities
- -
2.1 Payments to acquire or for:
(a) entities
(b) businesses - -
(c) property, plant and equipment - -
(d) investments - -
(e) intellectual property - -
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 2
+ See chapter 19 of the ASX Listing Rules for defined terms.
Consolidated statement of cash flows Current quarter
$A’000
Year to date
(6 months)
$A’000
(f) other non-current assets - -
2.2 Proceeds from disposal of:
- -
(a) entities
(b) businesses - -
(c) property, plant and equipment - -
(d) investments - -
(e) intellectual property - -
(f) other non-current assets - -
2.3 Cash flows from loans to other entities - -
2.4 Dividends received (see note 3) - -
2.5 Other (provide details if material) - -
2.6 Net cash from / (used in) investing
activities
- -
3. Cash flows from financing activities
- -
3.1 Proceeds from issues of equity securities
(excluding convertible debt securities)
3.2 Proceeds from issue of convertible debt
securities
- -
3.3 Proceeds from exercise of options - -
3.4 Transaction costs related to issues of
equity securities or convertible debt
securities
- -
3.5 Proceeds from borrowings - -
3.6 Repayment of borrowings - -
3.7 Transaction costs related to loans and
borrowings
- -
3.8 Dividends paid - -
3.9 Other (provide details if material) - -
3.10 Net cash from / (used in) financing
activities
- -
4. Net increase / (decrease) in cash and
cash equivalents for the period
3,166 5,049
4.1 Cash and cash equivalents at beginning of
period
4.2 Net cash from / (used in) operating
activities (item 1.9 above)
(578) (2,461)
4.3 Net cash from / (used in) investing activities
(item 2.6 above)
- -
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 3
+ See chapter 19 of the ASX Listing Rules for defined terms.
Consolidated statement of cash flows Current quarter
$A’000
Year to date
(6 months)
$A’000
4.4 Net cash from / (used in) financing activities
(item 3.10 above)
- -
4.5 Effect of movement in exchange rates on
cash held
- -
4.6 Cash and cash equivalents at end of
period
2,588 2,588
5. Reconciliation of cash and cash
equivalents
at the end of the quarter (as shown in the
consolidated statement of cash flows) to the
related items in the accounts
Current quarter
$A’000
Previous quarter
$A’000
5.1 Bank balances 1,088 666
5.2 Call deposits 1,500 2,500
5.3 Bank overdrafts - -
5.4 Other - -
5.5 Cash and cash equivalents at end of
quarter (should equal item 4.6 above)
2,588 3,166
6. Payments to related parties of the entity and their
associates
Current quarter
$A'000
6.1 Aggregate amount of payments to related parties and their
associates included in item 1
189
6.2 Aggregate amount of payments to related parties and their
associates included in item 2
-
Note: if any amounts are shown in items 6.1 or 6.2, your quarterly activity report must include a description of, and an
explanation for, such payments.
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 4
+ See chapter 19 of the ASX Listing Rules for defined terms.
7. Financing facilities
Note: the term “facility’ includes all forms of financing
arrangements available to the entity.
Add notes as necessary for an understanding of the
sources of finance available to the entity.
Total facility
amount at quarter
end
$A’000
Amount drawn at
quarter end
$A’000
7.1 Loan facilities - -
7.2 Credit standby arrangements - -
7.3 Other (At-the-Market Facility) 7,500 -
7.4 Total financing facilities 7,500 -
7.5 Unused financing facilities available at quarter end 7,500
7.6 Include in the box below a description of each facility above, including the lender, interest
rate, maturity date and whether it is secured or unsecured. If any additional financing facilities
have been entered into or are proposed to be entered into after quarter end, include a note
providing details of those facilities as well.
7.3. On 22 August 2025, the Company entered into an At-the-Market Subscription Agreement
(ATM) with Acuity Capital. The ATM provides Cynata with up to $7,500,000 of standby equity
capital upto 31 July 2030. There are no requirements on Cynata to utilise the ATM and Cynata
may terminate the ATM at any time, without any cost or penalty. Additionally, Acuity Capital
is not obliged to subscribe for shares if or when requested by Cynata. Consequently, this
facility has not been included in item 8.3 below.
At 31 December 2025, the Company had not utilised the ATM facility. Subsequent to the
quarter end, on 23 January 2026, the Company utilised the ATM to raise $1,204,000 through
the set-off of 4,300,000 fully paid ordinary Cynata shares previously issued to Acuity Capital.
8. Estimated cash available for future operating activities $A’000
8.1 Net cash from / (used in) operating activities (item 1.9) (578)
8.2 Cash and cash equivalents at quarter end (item 4.6) 2,588
8.3 Unused finance facilities available at quarter end (item 7.5) - (see item 7.6)
8.4 Total available funding (item 8.2 + item 8.3) 2,588
8.5 Estimated quarters of funding available (item 8.4 divided by
item 8.1)
4.5
Note: if the entity has reported positive net operating cash flows in item 1.9, answer item 8.5 as “N/A”. Otherwise, a
figure for the estimated quarters of funding available must be included in item 8.5.
8.6 If item 8.5 is less than 2 quarters, please provide answers to the following questions:
8.6.1 Does the entity expect that it will continue to have the current level of net operating
cash flows for the time being and, if not, why not?
N/A
8.6.2 Has the entity taken any steps, or does it propose to take any steps, to raise further
cash to fund its operations and, if so, what are those steps and how likely does it
believe that they will be successful?
N/A
8.6.3 Does the entity expect to be able to continue its operations and to meet its business
objectives and, if so, on what basis?
N/A
Note: where item 8.5 is less than 2 quarters, all of questions 8.6.1, 8.6.2 and 8.6.3 above must be answered.
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 5
+ See chapter 19 of the ASX Listing Rules for defined terms.
Compliance statement
1 This statement has been prepared in accordance with accounting standards and policies which
comply with Listing Rule 19.11A.
2 This statement gives a true and fair view of the matters disclosed.
Date: 29 January 2026
Authorised by: By the Board
(Name of body or officer authorising release – see note 4)
Notes
1. This quarterly cash flow report and the accompanying activity report provide a basis for informing the market about the
entity’s activities for the past quarter, how they have been financed and the effect this has had on its cash position. An
entity that wishes to disclose additional information over and above the minimum required under the Listing Rules is
encouraged to do so.
2. If this quarterly cash flow report has been prepared in accordance with Australian Accounting Standards, the definitions
in, and provisions of, AASB 107: Statement of Cash Flows apply to this report. If this quarterly cash flow report has been
prepared in accordance with other accounting standards agreed by ASX pursuant to Listing Rule 19.11A, the
corresponding equivalent standard applies to this report.
3. Dividends received may be classified either as cash flows from operating activities or cash flows from investing activities,
depending on the accounting policy of the entity.
4. If this report has been authorised for release to the market by your board of directors, you can insert here: “By the board”.
If it has been authorised for release to the market by a committee of your board of directors, you can insert here: “By the
[name of board committee – eg Audit and Risk Committee]”. If it has been authorised for release to the market by a
disclosure committee, you can insert here: “By the Disclosure Committee”.
5. If this report has been authorised for release to the market by your board of directors and you wish to hold yourself out as
complying with recommendation 4.2 of the ASX Corporate Governance Council’s Corporate Governance Principles and
Recommendations, the board should have received a declaration from its CEO and CFO that, in their opinion, the financial
records of the entity have been properly maintained, that this report complies with the appropriate accounting standards
and gives a true and fair view of the cash flows of the entity, and that their opinion has been formed on the basis of a
sound system of risk management and internal control which is operating effectively.
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